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Recall Observatory FDA recall evidence

Drug product

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

D-0934-2023

July 07, 2023

Class II

Product summary

Firm
SterRx, LLC
Event
Event 92657
Status
Terminated
Classification
Class II
Quantity
2,088 bags
Official record key
drug-enforcement:D-0934-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 490100, Exp 27-Jul-23

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility